Effect of Occlusal Reduction on Relief of Pain and Sensitivity to Percussion in Patients With Irreversible Pulpitis
Primary Purpose
Post Operative Pain, Post-Op Complication
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Occlusal reduction
Sponsored by
About this trial
This is an interventional prevention trial for Post Operative Pain focused on measuring Occlusal reduction
Eligibility Criteria
Inclusion Criteria:
- No medical history
- patients suffering from Symptomatic Irreversible Pulpitis
- patients suffering from Apical Periodontitis
- patients requiring porcelain fused to metal crown
Exclusion Criteria:
- Patients who were not suitable for conventional root canal treatment
- multirooted teeth
Sites / Locations
- Hira Danish
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
occlusal reduction
control
Arm Description
Performing occlusal reduction on the experimental tooth until absence of occlusal contact is confirmed following completion of the endodontic treatment
No occlusal reduction or modification of the occlusal anatomy will be performed
Outcomes
Primary Outcome Measures
Post Obturation pain
Postobturation pain is measured using the visual analogue scale(VAS) with readings from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
Tenderness to percussion
Tenderness to percussion will be evaluated (score 0: no pain, score 1: slight pain score 2: severe pain)
Secondary Outcome Measures
Incidence of placebo and analgesic intake
The incidence of placebo and number analgesic taken will be recorded by the patient
Full Information
NCT ID
NCT05306535
First Posted
March 15, 2022
Last Updated
August 21, 2022
Sponsor
Altamash Institute of Dental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05306535
Brief Title
Effect of Occlusal Reduction on Relief of Pain and Sensitivity to Percussion in Patients With Irreversible Pulpitis
Official Title
Effect of Occlusal Reduction on Relief of Pain and Sensitivity to Percussion in Patients With Irreversible Pulpitis and Symptomatic Apical Periodontitis Treated in a Single Visit- a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Altamash Institute of Dental Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
One of the most important aspects of endodontic practice is to abate pain during and post root canal treatment. An endodontist by all means should provide a painless endodontic treatment to their patients. This study is carried out to determine the effect of occlusal reduction on relief of pain and percussion in patients with irreversible pulpitis and symptomatic apical periodontitis treated in a single visit root canal treatment. Pain will be assessed preoperatively and then post operatively after completion of the root canal at 6 hours, 12 hours, 24 hours, 48 hours and 72 hours following obturation of root canal.
Detailed Description
The objective of this randomized clinical trial is to evaluate the impact of occlusal reduction on the incidence of post obturation pain. 56 patients will be allocated randomly into 2 groups keeping 28 patients in each group which will meet the inclusion criteria of the study, patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis and requiring porcelain fused to metal crown with age ranging from 18 to 50 years. In the interventional group 2mm reduction will be done and assessment will be done to confirm the absence of occlusal contact while in control group no modification will be carried out on the occlusal surface. Single visit endodontic treatment will be carried out with 2.5% sodium hypochlorite for disinfection of the canal followed by crown down technique using rotary nickel titanium files for shaping the canals followed by obturating the canals with lateral condensation technique.
Pain will be assessed preoperatively and then post operatively at 6 hours, 12 hours, 24 hours, 48 hours and 72 hours following obturation of root canal. Visual Analogue Scale (VAS) will be used as a primary outcome measure.The VAS consists of a 10-cm line having two extremes NO PAIN and Extreme pain. Patients will be asked to choose the mark that represents their level of pain at the intervals mentioned above . Pain level are assigned to one of four categorical scores
1, None(0); 2, Mild (1-3) ; 3 Moderate (4-6); 4, Severe (7-10) 10. Tenderness to percussion will be evaluated postoperatively at 48 hour with readings either positive to tenderness or negative to tenderness Positive to tenderness will evaluate treatment not effective Negative to tenderness at 48 hour post obturation will evaluate treatment effectiveness Patients will be given placebo for administration in case severe pain and ibuprofen 400mg if the pain persisted. Documentation of intake of either placebo or analgesic will be done by the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Post-Op Complication
Keywords
Occlusal reduction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
occlusal reduction
Arm Type
Experimental
Arm Description
Performing occlusal reduction on the experimental tooth until absence of occlusal contact is confirmed following completion of the endodontic treatment
Arm Title
control
Arm Type
No Intervention
Arm Description
No occlusal reduction or modification of the occlusal anatomy will be performed
Intervention Type
Procedure
Intervention Name(s)
Occlusal reduction
Intervention Description
Occlusal reduction of the experimental single rooted tooth after root canal completion will be done to evaluation reduction in postoperative pain and sensitivity to percussion
Primary Outcome Measure Information:
Title
Post Obturation pain
Description
Postobturation pain is measured using the visual analogue scale(VAS) with readings from 0-10 where 0 represents no pain and 10 represents the worst pain measured.
Time Frame
6 hours upto 48 hours following obturation
Title
Tenderness to percussion
Description
Tenderness to percussion will be evaluated (score 0: no pain, score 1: slight pain score 2: severe pain)
Time Frame
At 48 hours post completion of the root canal treatment
Secondary Outcome Measure Information:
Title
Incidence of placebo and analgesic intake
Description
The incidence of placebo and number analgesic taken will be recorded by the patient
Time Frame
from 6 hours up to 48 hours following completion of root canal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No medical history
patients suffering from Symptomatic Irreversible Pulpitis
patients suffering from Apical Periodontitis
patients requiring porcelain fused to metal crown
Exclusion Criteria:
Patients who were not suitable for conventional root canal treatment
multirooted teeth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hira Danish
Organizational Affiliation
Employee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hira Danish
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75500
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Occlusal Reduction on Relief of Pain and Sensitivity to Percussion in Patients With Irreversible Pulpitis
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